418 results
Categories
Human Remove Human filter
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Medicine type
Orphan medicine Remove Orphan medicine filter
-
List item
Human medicine European public assessment report (EPAR): Xospata (updated)
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,,
, Revision: 5, Authorised, Last updated: 07/11/2023
-
List item
Human medicine European public assessment report (EPAR): Opsumit (updated)
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 23, Authorised, Last updated: 07/11/2023
-
List item
Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (updated)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,,
, Revision: 4, Authorised, Last updated: 06/11/2023
-
List item
Human medicine European public assessment report (EPAR): Tavneos
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,,
, Revision: 4, Authorised, Last updated: 03/11/2023
-
List item
Human medicine European public assessment report (EPAR): Minjuvi
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,,
,
, Revision: 4, Authorised, Last updated: 31/10/2023
-
List item
Human medicine European public assessment report (EPAR): Yescarta
Axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,,
, Revision: 12, Authorised, Last updated: 30/10/2023
-
List item
Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,,
,
, Revision: 9, Authorised, Last updated: 30/10/2023
-
List item
Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,,
,
, Revision: 16, Authorised, Last updated: 27/10/2023
-
List item
Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
,
, Revision: 7, Authorised, Last updated: 25/10/2023
-
List item
Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,,
, Revision: 7, Authorised, Last updated: 20/10/2023
-
List item
Human medicine European public assessment report (EPAR): Zolgensma
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
,
, Revision: 13, Authorised, Last updated: 18/10/2023
-
List item
Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,,
,
, Revision: 9, Authorised, Last updated: 18/10/2023
-
List item
Human medicine European public assessment report (EPAR): Filsuvez
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Revision: 2, Authorised, Last updated: 17/10/2023
-
List item
Human medicine European public assessment report (EPAR): Farydak
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,, Revision: 13, Authorised, Last updated: 13/10/2023
-
List item
Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,,
, Revision: 14, Authorised, Last updated: 12/10/2023
-
List item
Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 28, Authorised, Last updated: 12/10/2023
-
List item
Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, Revision: 11, Authorised, Last updated: 11/10/2023
-
List item
Human medicine European public assessment report (EPAR): Reblozyl
Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020,,
, Revision: 5, Authorised, Last updated: 09/10/2023
-
List item
Human medicine European public assessment report (EPAR): Tepkinly
epcoritamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/09/2023,,
,
, Authorised, Last updated: 05/10/2023
-
List item
Human medicine European public assessment report (EPAR): Kimmtrak
tebentafusp, Uveal Neoplasms
Date of authorisation: 01/04/2022,,
, Revision: 1, Authorised, Last updated: 05/10/2023
-
List item
Human medicine European public assessment report (EPAR): SomaKit TOC
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 15, Authorised, Last updated: 29/09/2023
-
List item
Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,,
, Revision: 11, Authorised, Last updated: 28/09/2023
-
List item
Human medicine European public assessment report (EPAR): Trepulmix
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 4, Authorised, Last updated: 27/09/2023
-
List item
Human medicine European public assessment report (EPAR): Hyftor
Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023,, Revision: 2, Authorised, Last updated: 25/09/2023
-
List item
Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 7, Authorised, Last updated: 25/09/2023